President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector
On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy Roosevelt’s trust-busting and Franklin Roosevelt’s “supercharged antitrust enforcement”. Asserting that a “fair, open, and competitive marketplace has long been the cornerstone of the American economy,” the Executive Order sets forth 72 initiatives across over a dozen federal agencies.
Notably, a number of these initiatives focus on the healthcare sector, among them, a direction to the Secretary of Health and Human Services to:
> “ lower the prices of and improve access to prescription drugs and biologics, [and] continue to promote generic drug and biosimilar competition ,” including by: (a) clarifying the approval framework for generic drugs and biosimilars, and the standards for interchangeability of biological products; (b) “supporting biosimilar product adoption;” (c) facilitating “the development and approval of biosimilar and interchangeable products;” and (d) “identifying and addressing any efforts to impede generic drug and biosimilar competition, including but not limited to false, misleading, or otherwise deceptive statements about generic drug and biosimilar products and their safety or effectiveness;”
“ ensure that the patent system, while […]